Daunorubicin Injection Suppliers & Bulk Manufacturers

Available Forms: Intravenous (IV) injection:

Available Strengths: 20 mg/mL

Reference Brands: Cerubidine(US)

Category: Blood Disorder

Daunorubicin injection is available in Intravenous (IV) injection: and strengths such as 20 mg/mL. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Daunorubicin injection is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Daunorubicin injection can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

Product Description: Daunorubicin injection, marketed as Cerubidine, is approved in the US by the FDA and in the EU via EMA for treating leukemia, primarily acute myeloid leukemia. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, submission involves detailed review by the FDA, whereas in the EU, the EMA ensures compliance with regional quality standards. For expert guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring adherence to regional regulations is essential for the safe, effective, and timely approval of daunorubicin injection worldwide, supporting optimal patient treatment outcomes.